Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

Sanofi

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: Teriflunomide; Drug: Placebo (placebo for teriflunomide)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01487096

HMR1726D/2001

Details and patient eligibility

About

The primary objective of this study was to determine the safety and efficacy of teriflunomide in multiple sclerosis (MS) with relapses.

Secondary objectives were:

• To determine the effect of teriflunomide on additional magnetic resonance imaging (MRI) variables as well as clinical and quality of life measures.
• To investigate the pharmacokinetic and pharmacodynamic relationships.

Full description

The total duration of the study period per participants was 46 weeks comprising 3 periods:

• a 4-week screening period,
• a 36-week double-blind treatment period,
• a 6-week post-treatment follow-up period.

Participants who successfully completed the double-blind treatment phase were offered the possibility to continue study treatment in the extension study LTS6048 - NCT00228163.

Enrollment: 179 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically confirmed multiple sclerosis [MS];
• Expanded Disability Status Scale [EDSS] score less or equal to 6;
• Two documented relapses in the previous 3 years, and one clinical relapse during the preceding year;
• Screening magnetic resonance imaging [MRI] scan fulfilling the criteria for a diagnosis of MS.

Exclusion criteria

• Clinically relevant cardiovascular, hepatic, hematologic, neurological, endocrine or other major systemic disease;
• Pregnant or nursing woman;
• Wish to parent children during the trial or following the trial (men and women were required to practice effective contraception during the trial and for 24 months after drug discontinuation);
• Prior treatment with interferon [IFN], gamma-globulin, glatiramer acetate, or other noncorticosteroid immunomodulatory therapies in the 4 months prior to the trial;
• Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
• Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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179 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo (for teriflunomide), * two tablets once daily for 1 week then, * one tablet once daily for 35 weeks.

Treatment:

Drug: Placebo (placebo for teriflunomide)

Teriflunomide 7 mg

Experimental group

Description:

Teriflunomide 7 mg: * two tablets once daily for 1 week then, * one tablet once daily for 35 weeks.

Treatment:

Drug: Teriflunomide

Teriflunomide 14 mg

Experimental group

Description:

Teriflunomide 14 mg: * two tablets once daily for 1 week then, * one tablet once daily for 35 weeks.

Treatment:

Drug: Teriflunomide